MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TRAUMACEM(TM) V+ INJECTABLE BONE CEMENT ¿ STERILE; POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT

Catalog Number 07.702.040S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown.The 510k: this report is for an unknown traumacem v+ cement/unknown lot.Part and lot number are unknown; udi number is unknown.Device has not been reported as explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4) used to capture the cement hardening too quickly preventing the injection device from being removed.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during augmentation of trochanteric fixation nail advanced (tfna) the traumacem v+ cement hardened quite fast.Because of this it was not possible to remove the cement cannula.It broke and part of the cannula remained in the blade.The surgery was prolonged about ten (10) minutes.There was no patient harm and the outcome was reported as normal.Concomitant device: tfna blade (part/lot unknown, quantity 1).This report is for unknown traumacem v+ cement.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Concomitant device: nail head element (part/lot unknown, quantity 1).

• Brand Name: TRAUMACEM(TM) V+ INJECTABLE BONE CEMENT ¿ STERILE
• Type of Device: POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7479594
• MDR Text Key: 107109005
• Report Number: 8030965-2018-53495
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• PMA/PMN Number: K170802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.702.040S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention